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FDA 510(k) Application Details - K121994
Device Classification Name
Radioassay, Vitamin B12
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510(K) Number
K121994
Device Name
Radioassay, Vitamin B12
Applicant
Siemens Healthcare Diagnostics Inc.
500 GBC DRIVE
NEWARK, DE 19714 US
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Contact
A. KATHLEEN B ENNIS
Other 510(k) Applications for this Contact
Regulation Number
862.1810
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Classification Product Code
CDD
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More FDA Info for this Product Code
Date Received
07/06/2012
Decision Date
11/30/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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